Effect of Low Flow Anesthetics on Neurocognitive Decline in the Elderly

Neurocognitive Disorders Clinical Trial

Official title:

Effect of Low Fresh Gas Flow Volatile Anesthetics on Postoperative Neurocognitive Function in Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05548998
• Other study ID #: 1206
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: November 1, 2019

Study information

• Verified date: September 2022
• Source: Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to investigate the effect of inhaled anesthetics with a low fresh gas flow on cognitive function of elderly patients undergoing elective surgery

Description:

Geriatric patients scheduled to undergo surgery were tested with Mini Mental State Examination (MMSE) in the preoperative visit. MMSE was repeated postoperatively at the 6th hour, the 1st, 3rd, and 7th day. Visual analogue scale (VAS) test was performed simultaneously on the postoperative 6th hour, the 1st, 3rd, and 7th day. Two cohorts were created according to the amount of fresh gas flow (low flow vs high flow) in the maintenance phase of the inhalational anesthetic. MMSE scores were compared between cohorts and baseline. VAS scores were compared between cohorts.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age>65

• Consenting to participate

• Scheduled for surgery longer than 2 hours under GA

• Able to read and write

Exclusion Criteria:

• Age<65

• Refusing to participate

• Existing visual impairment preventing the patient from reading or writing

• Unable to read and write

• Existing major neurocognitive disorder

• Use of TIVA or regional techniques

• Allergies to the volatile agents

• Uncontrolled DM, acute alcohol intoxication

• Conditions increasing tissue oxygen consumption (sepsis, thyrotoxicosis, etc.)

• Anticipation/existence of major hemorrhage

• Haemodynamic instability > 10 min or more than 5 times intraoperatively

Related Conditions & MeSH terms

• Inhalation; Vapor
• Neurocognitive Disorders

Intervention

Other:
• General anesthesia with low fresh gas flow
General anesthesia with a fresh gas flow lower than 1L/min for the maintenance phase of anesthesia
• General anesthesia with high fresh gas flow
General anesthesia with a fresh gas flow equal to or higher than 1L/min for the maintenance phase of anesthesia

Diagnostic Test:
• Mini mental state examination
6 category and 30-point test to inquire patient's cognitive function
• Visual Analogue Scale
The patient's self-reported pain intensity according to a visual scale between 0 and 100

Locations

Country	Name	City	State
Turkey	Prof. Dr. Cemil Tascioglu City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 24th hour	A Mini-Mental State Examination (MMSE) is a set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory).	Baseline and postoperative day 1
Secondary	Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 6th hour	A Mini-Mental State Examination (MMSE) is a set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory).	Baseline and postoperative hour 6
Secondary	Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 3rd day	A Mini-Mental State Examination (MMSE) is a set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory).	Baseline and postoperative day 3
Secondary	Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 7th day	A Mini-Mental State Examination (MMSE) is a set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory).	Baseline and postoperative day 7
Secondary	Change from baseline in pain on the 10 point VAS scale at postoperative 6th hour	The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge	Baseline and postoperative hour 6
Secondary	Change from baseline in pain on the 10 point VAS scale at postoperative 24th hour	The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge	Baseline and postoperative hour 24
Secondary	Change from baseline in pain on the 10 point VAS scale at postoperative 3rd day	The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge	Baseline and postoperative day 3
Secondary	Change from baseline in pain on the 10 point VAS scale at postoperative 7th day	The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge	Baseline and postoperative day 7